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This is a randomized, placebo-controlled, double blind, parallel group, multicenter study of participants, age 12 to 65 years, with SCD. The key purpose for the study is to establish efficacy and safety of voxelotor as compared with placebo.

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Layout table for eligibility information

Ages Eligible for Study:

12 Years to 65 Years (Child, Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female study participants with sickle cell disease

Participants have had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12 months.

Age 12 to 65 years

Hemoglobin (Hb) ≥5.5 and ≤10.5 g/dL during screening

For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at least 3 months prior to signing the ICF.

Exclusion Criteria:

More than 10 VOCs within the past 12 months that required a hospital, emergency room or clinic visit

Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or have received a RBC transfusion for any reason within 60 days of signing the ICF

Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to signing the ICF)